The FDA approved Afrezza, an inhalable diabetes medication to help patients control their blood sugar levels during meals. / Damion Edwards for MannKind

by Tom Wilemon, The Tennessean

by Tom Wilemon, The Tennessean

The U.S. Food and Drug Administration has approved a new insulin drug that will allow diabetics to set needles aside at mealtimes and use inhalers instead.

Afrezza Inhalation Powder, however, is not a substitute for long-acting insulin. The new drug is intended to be used in combination with long-acting insulin for patients with type 1 diabetes, the FDA said. However, a clinical trial showed that Afrezza was effective in treating both types of diabetes. People with type 2 diabetes can use it in combination with oral antidiabetic drugs.

"Today's approval broadens the options available for delivering mealtime insulin in the overall management of patients with diabetes who require it to control blood sugar levels," Dr. Jean-Marc Guettier, the FDA director in charge of diabetes products evaluations, said Friday.

The clinical trial involved 1,026 people with type 1 diabetes and 1,991 people with type 2 diabetes.

The inhalant should be administered at the beginning of each meal or within 20 minutes after starting a meal.

The rapid-acting therapy was developed by California-based MannKind Corp. The company said in a press release that peak insulin levels are achieved within 12 to 15 minutes of administration of insulin with Afrezza, compared with 45 minutes to 90 minutes with injected, rapid-acting insulin.

The FDA approved Afrezza with a boxed warning â?? the strongest type â?? indicating that the drug should not be used in patients with chronic lung diseases, such as asthma and smoker's cough, due to reports of breathing spasms. The agency is also requiring several follow-up studies looking at the drug's long-term safety, including its impact on the heart and lungs.

Just over 29 million people in the United States have diabetes, according to the U.S. Centers for Disease Control and Prevention.

Friday's approval comes more than three years after the agency first asked MannKind to run additional clinical studies on the drug.

Demand for diabetes treatments is surging globally as the prevalence of obesity explodes. According to the World Health Organization, roughly 347 million people worldwide have the disease, a chronic condition in which the body either does not make enough insulin to break down the sugar in foods or uses insulin inefficiently. It can lead to blindness, strokes, heart disease or death. In type 2 diabetes, the most common form of the disease, the body does not use insulin properly. Type 1 diabetes is usually diagnosed in children and young adults. In those cases, the body does not produce insulin.

Several other companies have failed to make inhaled insulin work commercially. In 2007, Pfizer Inc. discontinued its inhaled insulin Exubera after it failed to gain ground on the market. In 2008, Eli Lilly & Co. ended its development program, citing regulatory uncertainty.